Incidental Lung NoduleCARANOD-IANCT03843164
Lung Nodule Characterization by Artificial Intelligence Techniques
An observational study of Incidental Lung Nodule, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Management of incidental lung nodule is difficult and mainly based on simple morphometric characteristics such as maximum size and shape. Radiomics could play a role in simplifying this management by orientating towards a benign or a malignant origin, by comparing advanced characteristics to a large database of lung… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incidental Lung Nodule
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 12 Mar 2019to Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with a chest CT acquired between Jan 1 2012 and Oct 1 2018 at the Strasbourg University Hospital;
Who may be able to join
- Adult patient (at least 18 years old);
- With a chest CT acquired between Jan 1 2012 and Oct 1 2018 at the Strasbourg University Hospital;
- CT being available over the PACS and exhibiting at least one lung nodule;
- Patient having given its authorization for the exploitation of his medical data for this research.
Who cannot join
- Patient having expressed direct opposition to participation in this study;
- Patient under juridical protection;
- Patient under tutelage or guardianship.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Radiologie B - NHC
Strasbourg, 67091
Mickaël OHANA, MD, 33 3 69 55 11 17, mickael.ohana@chru-strasbourg.fr
Aissam LABANI, MD, 33 3 69 55 11 17, aissam.labani@chru-strasbourg.fr
About this study
Management of incidental lung nodule is difficult and mainly based on simple morphometric characteristics such as maximum size and shape. Radiomics could play a role in simplifying this management by orientating towards a benign or a malignant origin, by comparing advanced characteristics to a large database of lung nodules.
The primary purpose is to evaluate the performances of a novel tool based on radiomics to characterize incidental lung nodules, discovered on computed tomography.
Read more
The secondary objectives are:
- to evaluate the variation in the performances of the software based on various technical aspects of the CT, such as radiation dose, reconstruction algorithm, type of scanner,…
- to compare the performances of this software to those of expert readers,
- to analyze the potential impact of this software on patient's management.
- Conditions
- Incidental Lung Nodule
- Keywords
- Solitary Pulmonary Nodule, Multidetector Computed Tomography, Artificial Intelligence
- Medical subject headings
- Solitary Pulmonary Nodule
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the performances of a novel tool based on radiomics to characterize incidental lung nodules, discovered on computed tomography.
The study concerns patients who performed a chest CT scan at Strasbourg University Hospitals between 01/01/2012 and 01/10/2018
Measured: he period from January 1st, 2012 to October 01, 2018 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start12 Mar 2019
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incidental Lung NoduleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843164
- Sponsor's protocol ID
- 7311
- Acronym
- CARANOD-IA
- Status last verified
- Feb 2019
- First submitted
- 13 Feb 2019
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Nodule Characterization by Artificial Intelligence Techniques
- ClinicalTrials.gov ID
- NCT03843164
- Acronym / sponsor ID
- CARANOD-IA / 7311
- Conditions
- Incidental Lung Nodule
- Keywords
- Solitary Pulmonary Nodule, Multidetector Computed Tomography, Artificial Intelligence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 12 Mar 2019 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Management of incidental lung nodule is difficult and mainly based on simple morphometric characteristics such as maximum size and shape. Radiomics could play a role in simplifying this management by orientating towards a benign or a malignant origin, by comparing advanced characteristics to a large database of lung nodules.
The primary purpose is to evaluate the performances of a novel tool based on radiomics to characterize incidental lung nodules, discovered on computed tomography.
The secondary objectives are:
- to evaluate the variation in the performances of the software based on various technical aspects of the CT, such as radiation dose, reconstruction algorithm, type of scanner,…
- to compare the performances of this software to those of expert readers,
- to analyze the potential impact of this software on patient's management.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with a chest CT acquired between Jan 1 2012 and Oct 1 2018 at the Strasbourg University Hospital;
Key inclusion criteria (4 listed)
- Adult patient (at least 18 years old);
- With a chest CT acquired between Jan 1 2012 and Oct 1 2018 at the Strasbourg University Hospital;
- CT being available over the PACS and exhibiting at least one lung nodule;
- Patient having given its authorization for the exploitation of his medical data for this research.
Key exclusion criteria (3 listed)
- Patient having expressed direct opposition to participation in this study;
- Patient under juridical protection;
- Patient under tutelage or guardianship.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the performances of a novel tool based on radiomics to characterize incidental lung nodules, discovered on computed tomography.
Time frame: he period from January 1st, 2012 to October 01, 2018 will be examined
The study concerns patients who performed a chest CT scan at Strasbourg University Hospitals between 01/01/2012 and 01/10/2018
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Incidental Lung Nodule, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mickaël OHANA, MD (33 3 69 55 11 17, mickael.ohana@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the performances of a novel tool based on radiomics to characterize incidental lung nodules, discovered on computed tomography. (time frame: he period from January 1st, 2012 to October 01, 2018 will be examined). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019.